Active not recruitingPHASE1INTERVENTIONAL

A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)

This study is looking at a new medicine called MK-6837 for people with advanced cancers that have spread and haven't gotten better with standard treatments. The medicine will be given on its own or together with another drug called pembrolizumab. The main things the researchers want to find out are if MK-6837 is safe to use and if people can tolerate its side effects. They will also look for early signs of whether it helps treat the cancer. This is an early-stage study, meaning it's one of the first times this new medicine is being tested in people. It will help doctors understand more about this potential new treatment.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

168

Start

14 Jul 2024

Estimated completion

13 Jul 2027

Neoplasm Metastasis

What is this study about?

This research study is about a new medicine called MK-6837. Cancers are sometimes called 'solid tumors,' and if they've spread to other parts of the body, they're called 'advanced' or 'metastatic.' For people whose cancers haven't improved with typical treatments, doctors are always looking for new options. That's where this study comes in. They want to see if MK-6837 could be a helpful treatment.

In this study, some people will receive MK-6837 on its own, while others will get it alongside an existing cancer drug called pembrolizumab. Pembrolizumab is a type of immunotherapy that helps your body's immune system fight cancer. By testing MK-6837 in these ways, the researchers hope to understand its effects better.

The main focus of this first stage of the study (Phase 1) is to check the safety of MK-6837 and how well people cope with any side effects. They'll also be looking for early signs that the medicine might be helping to shrink or control the cancer. This kind of early study doesn't aim to prove the drug works, but rather to gather important information to decide if it's safe and promising enough for further, larger studies.

Key takeaways

New medicine (MK-6837) being tested for advanced cancers.
For cancers that haven't responded to usual treatments.
Being tested alone and with another drug (pembrolizumab).
Main focus is on safety and how well people tolerate it.
Early stage (Phase 1) study.
You can leave the study at any time.

Who may be eligible?

To join this study, you would need to have an advanced cancer (a 'solid tumor') that has been confirmed by a doctor, and it must have spread to other parts of your body. Also, your current cancer treatments must not have worked well enough.

There are also some important health conditions that would prevent you from taking part. For example, if you have severe heart problems or a history of certain difficult reactions to other immunotherapy drugs, you might not be eligible. If you've had another cancer recently, you might also not be able to join.

If you have conditions like HIV or Hepatitis B/C, you might still be able to join if these conditions are well-managed and under control with treatment. You will also need to have recovered from any serious side effects from previous cancer treatments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have an advanced solid cancer that has spread?
Has my cancer not responded to previous standard treatments?
Do I have any serious heart conditions?
Have I fully recovered from side effects of previous cancer treatments?
Have I had another cancer diagnosis in the last two years that wasn't fully cured?
Am I willing to stop other anti-cancer treatments for a period before starting the study?

Answer every question to see your result.

What does participation involve?

The detailed information about what participating in this study involves isn't fully provided here, but generally, in a clinical trial like this, you would have regular visits to the hospital or clinic. These visits typically involve physical examinations, blood tests, and scans (like CT or MRI) to monitor your health and how the treatment is affecting your cancer. You would receive the study medication, MK-6837, and possibly pembrolizumab, according to a set schedule. Doctors and nurses will watch you closely for any side effects.

There would also be periods of follow-up after your treatment to see how you are doing in the longer term. The total duration of your participation would depend on how your body responds to the treatment and the study plan, but it could range from several months to a year or more. You'd be given clear instructions on when and how to take any medications and who to contact if you have concerns.

Potential risks and benefits

Like all medicines, especially new ones, MK-6837 could cause side effects. These risks are not fully known yet and will be carefully monitored. There's also no guarantee that the treatment will help your cancer. However, by taking part, you would receive close medical attention and access to a potential new treatment before it's widely available. You would also be contributing valuable information that could help others with cancer in the future. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

Atlantic Health System Morristown Medical Center ( Site 4001)
Verified postcode
Morristown, United States
Providence Portland Medical Center ( Site 4002)
Verified postcode
Portland, United States
South Texas Accelerated Research Therapeutics (START) ( Site 4003)
Verified postcode
San Antonio, United States
Westmead Hospital ( Site 1002)
Verified postcode
Westmead, Australia
The Alfred Hospital ( Site 1001)
Verified postcode
Melbourne, Australia
Princess Margaret Cancer Centre ( Site 2001)
Verified postcode
Toronto, Canada
Sheba Medical Center-ONCOLOGY ( Site 3001)
Verified postcode
Ramat Gan, Israel

Common questions

What kind of cancer is this study for?

This study is for people with advanced solid tumors (like breast, lung, bowel cancer, etc.) that have spread and haven't responded well to standard treatments.

What are the medicines being tested?

The study is testing a new medicine called MK-6837, both on its own and together with an existing cancer drug called pembrolizumab.

What is the main goal of the study?

The main goal is to find out if the new medicine, MK-6837, is safe and how well people tolerate it, as well as looking for early signs it might help treat cancer.

Can I join if I have HIV or Hepatitis B/C?

Possibly, yes. If your HIV or Hepatitis B/C is well-managed and under control with treatment, you might still be able to take part.

What if I experience side effects?

The study team will monitor you very closely for any side effects. You will have regular contact with doctors and nurses who can help manage any issues that arise.